Accelerated cancer drug approvals yield modest survival gains at significant Medicare cost

Early access to new cancer drugs, granted accelerated approval by the U.S. Food and Drug Administration (FDA), has provided mixed benefits for patients while costing Medicare billions of dollars, ...
Medscape

Accelerated Approval Pathway for Cancer Drugs: Does It Work?

Accelerated approvals for cancer drugs is a good idea in theory. This US Food and Drug Administration (FDA) pathway allows promising new cancer agents to reach the market, and patients, sooner. But ...
Seeking Alpha

DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old

DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study ...
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Navigating the FDA’s accelerated approval pathways for oncology drugs

“It would not be surprising to not see new FDA guidance documents issued for some period of time,” said David Larwood, CEO of Valley Fever Solutions, about the potential impact of the US Food and Drug ...
Medscape

Less Than 50% of Accelerated Approvals Show Clinical Benefit

SAN DIEGO — Fewer than half of the cancer drugs approved under the US Food and Drug Administration's (FDA's) accelerated approval pathway between 2013 and 2017 have been shown to improve overall ...
Nasdaq

Avidity Biosciences Announces the Accelerated Approval Regulatory Pathway in the U.S. is Open for Del-Brax and Initiates the Global, Confirmatory Phase 3 FORWARD™ Study in FSHD

SAN DIEGO, June 9, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide ...
Seeking Alpha

Compass Pathways outlines FDA engagement and accelerated pathways for COMP360 in TRD while advancing PTSD program

Nath stated, "We plan to meet with the FDA to discuss these results and explore next steps in getting COMP360 to patients as rapidly as possible." Loxam reiterated, "We are finalizing a PTSD study and ...